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Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cog… (NCT05182476) | Clinical Trial Compass
Phase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia Stopped: Failed to meet the primary endpoint
Plain-language summary Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
Who can participate Age range 18 Years – 50 Years
Sex ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓ . Completed written informed consent. ✓ . Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures. ✓ . Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). ✓ . The initial diagnosis of schizophrenia must be ≥1 year before screening. ✓ . The participant is currently receiving a stable regimen of psychotropic medications. ✓ . Participant has stable symptomatology ≥3 months before the screening visit. ✓ . The participant must have an adult informant. ✓ . A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m\^2), inclusive. ✕ . Pregnant or breastfeeding or plans to become pregnant during the study. ✕ . Exhibit more than a minimal level of extrapyramidal signs/symptoms. ✕ . Schizophrenia diagnosis occurred before 12 years of age. ✕ . Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder. ✕ . Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions. What they're measuring 1 Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score
Timeframe: Baseline, Day 98
Trial details NCT ID NCT05182476
Sponsor Neurocrine Biosciences
Sponsor type INDUSTRY
Study type INTERVENTIONAL
Primary completion 2024-06-28
✕ . Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
✕ . Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
✕ . Positive drug screen for disallowed substances.